MAUDE Adverse Event Report: 1.5MM/2.0MM CRUCIFORM SCREWDRIVER BLD W/HOLDING SLV

Model Number	314.67.96
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional patient identifier: (b)(6).The subject device has been received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2021, during an unknown procedure, the screw driver shaft would not be taken off from the handle.There was no surgical delay.The surgery was successfully completed.This report is for one (1) 1.5mm/2.0mm cruciform screwdriver bld w/holding slv.This is report 2 of 2 for complaint (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h4, h6- the 1.5/2.0 cruc screwdriver bld holding slv (part #: 314.67.96, lot #: unk) was received at us cq.Visual inspection of the complaint device showed the screwdriver was able to be disassembled from the handle.The distal prongs of the holding sleeve were bent and widely spread out.This complaint is confirmed as the distal prongs of the holding sleeve were bent and widely spread out.This defect could impact the functionality and the assembly with the handle.No root cause could definitively be determined for the reported complaint condition.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot = the device lot number is unknown, therefore a mre review could not be performed.If more information become available, the record will be re-assessed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 1.5MM/2.0MM CRUCIFORM SCREWDRIVER BLD W/HOLDING SLV
• Common Device Name: SCREWDRIVER
• MDR Report Key: 12569625
• Report Number: 2939274-2021-05897
• Device Sequence Number: 3322714
• Product Code: HXX
• UDI-Device Identifier: 10886982188991
• UDI-Public: (01)10886982188991
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 314.67.96
• Device Catalogue Number: 314.67.96
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Initial Date Received by Manufacturer: 09/07/2021
• Supplement Date Received by Manufacturer: 11/01/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 11/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: HANDLE WITH MINI QUICK COUPLING; HANDLE WITH MINI QUICK COUPLING
• Patient Age: 70 YR